FDA grants breakthrough device status for Genetesis’ CardioFlux MCG

Title: Genetesis’ CardioFlux MCG Receives Breakthrough Device Status from FDA


Genetesis’ CardioFlux magnetocardiography (MCG) has recently been granted breakthrough device status by the US Food and Drug Administration (FDA). The CardioFlux MCG is an innovative technology that uses magnetic fields to detect and diagnose heart ailments quickly and non-invasively. In this blog post, we will delve into the implications of the FDA’s breakthrough designation and the potential of the CardioFlux MCG in revolutionizing the diagnosis of heart disease.

Key Point 1: Introduction to Genetesis

Introduce Genetesis as a medical technology company that specializes in non-invasive diagnostics for heart disease. Discuss their cutting-edge research, development, and vision for bringing innovative medical technology to patients.

Key Point 2: Understanding Magnetic Fields for Heart Disease Diagnostics

Explain the concept of magnetic fields and their importance in diagnosing heart disease. Discuss how the CardioFlux MCG magnetically maps the heart’s electrical activity, creating a non-invasive, precise screening for heart disease.

Key Point 3: Breakthrough Device Designation

Explain why the FDA’s breakthrough device designation is significant for the CardioFlux MCG. Highlight how this designation recognizes the technological innovation and potential of this device to better diagnose and treat heart disease.

Key Point 4: The Potential of the CardioFlux MCG

Discuss the potential of the CardioFlux MCG to transform heart disease diagnostics by providing a quick, non-invasive method for detecting heart ailments. Mention its potential for greater accuracy, precision, and diagnostic potential compared to traditional electrocardiograms.

Key Point 5: Benefits for Health Care Providers

Discuss how the CardioFlux MCG could potentially benefit healthcare providers and their patients. Emphasize the ease of use and rapid diagnosis, enabling healthcare providers to make informed treatment decisions quickly and effectively.

Key Point 6: Patient Benefits and Improved Health Outcomes

Discuss how the CardioFlux MCG benefits patients by providing a non-invasive, more accurate diagnosis of heart disease. Highlight how this can lead to better outcomes, improved patient satisfaction, and reduced healthcare costs.

Key Point 7: Collaboration and Continued Research

Discuss how collaboration between industry, regulatory bodies, and research institutions is critical to advancing medical technology for heart disease diagnosis. Emphasize the importance of continued research, development, and clinical trials to validate the efficacy and safety of the CardioFlux MCG and bring it to market.


Summarize the key points discussed in the blog post, emphasizing the significance of the FDA’s breakthrough device designation for the CardioFlux MCG and its potential to revolutionize the diagnosis of heart disease. Highlight the importance of continued advancements in medical technology, collaboration, clinical trials, and innovation in the pursuit of better patient outcomes. Through these efforts, we can work towards improving the diagnosis and treatment of heart disease, ultimately improving the health and well-being of millions worldwide.